Personal Sound Amplification Products (PSAPs) have been the center of controversy among hearing care professionals for several years. This debate surrounding PSAPs is not without merit, as PSAPs are essentially unregulated by the FDA. Hearing care professionals are likely to recall the FDA in 2009 and 2013 issued what it refers to as “draft guidance” on the the intended use of PSAPs. This draft guidance states PSAPs are hearing enhancers intended for individuals with normal hearing.
While several studies indicate PSAPs are of poor sound quality, some other laboratory studies suggest that a few PSAPs are of comparable sound quality to conventional hearing aids. From consumers, however, who often are not privy to PSAP research, a balanced summary of PSAP pros and cons was published by Consumer Reports.
A February 2nd on-line article by Julia Calderone asked three Consumer Reports employees, diagnosed with mild to moderate hearing loss to try four PSAP devices priced from $20 to $350. Each person wore these devices for 3 to 7 days in every day listening situations. At the end of the trial, the employees’ ability to “pick out words in a noisy environment” was assessed. In addition, Consumer Reports enlisted the services of hearing aid researcher to objectively assess all of the PSAPs used in their trial.
Consistent with previous PSAP research inexpensive products costing less than $50 were judged to be of very poor quality and their use could further diminish a person’s ability to hear. On the other hand, two of the PSAPs evaluated by Consumer Reports were judged to be helpful for those with “early mild to moderate hearing loss in the high frequencies.”
To read the details of their trial, go here.
Julia Calderone posted a second article on PSAPs February 20th. In the follow-up article guidance was provided consumers on determining their own candidacy for a PSAP purchase. Specifically, the February 20th article focused on four questions that prospective PSAP buyers should ask before the purchase.
- Is a PSAP right for your hearing problems?
- Can you teach yourself to use the PSAP device?
- Are you clear on what the PSAP can do?
- Do PSAPs have a good return policy?
Industry experts Todd Ricketts of Vanderbilt University and Kim Cavitt of Northwestern University weighed in on these questions that were part of the February 20th article, which can be found here. These two aforementioned articles will also appear in the March 2017 issue of Consumer Reports.
According to Future Market Insights, an international business consulting firm, the PSAP market is expected to reach a global value of nearly $300 million by 2026. Given this solid growth figure, it is the contention of some industry experts that the creation of a new over-the-counter (OTC) hearing aid product category by the FDA will add some clarity to the PSAP controversy, as manufacturing guidelines and consumer labeling are likely to be part of the newly created OTC category sold directly to consumers. But until OTC devices become an official product category, consumers are more or less left to their own devices when deciding whether or not a PSAP is right for them.
**Interested readers can gain further knowledge and insights into PSAPs at the following links:
- PSAP Standard Review
- Recent PSAP and OTC Studies Warrant Cautious Interpretation
- Hearing Aid Distribution –V–PSAPs
- PSAP, ALD or Hearing Aid?
- PSAP and Hearables Market Encroachment — Part 1
If PSAP’s are not regulated by the FDA, then HIPAA rules should not apply, and also return for credit policies.
Anybody for comments on that?
The best way for a consumer to judge the viability of purchasing a PSAP is through self trial.
That is why some major consumer experiential marketing agencies are developing “hearing events” that allow people a Free Trial of PSAPS for up to 3 hours to better establish an opinion of the value of a PSAP in their everyday life.
Check out other articles on PSAPs on this HHTM Internet site to obtain additional insights into PSAPs and hearing aids. Find out what some of the studies that are reported, and not reported have to say about this issue.
Thank you Wayne, that is absolutely correct. HHTM has covered PSAPs and hearing aid technologies extensively over the years–of course you have authored many of those articles that provide a fantastic resource for interested professionals and consumers.
We’ve added some links at the end of the post providing additional references for our readers.
I think PSAP are important for those who are experiencing hearing loss and not ready to purchase hearing aids. They provide listening experiences when talking one-on-one at family gatherings and listening to the TV. Seniors who turn up the TV too loud and/or keep asking someone to repeat will be encouraged to socialize. A PSAP that includes a volume and tone control will help with the listening experience.